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GEM Premier 4000 PAK Cartridges for Use on the GEM Premier 4000 System: Class I Recall - Innaccurate Results

Mon, 08/01/2011 - 6:30am
U.S. Food & Drug Administration

AUDIENCE: Laboratory, Critical Care Medicine

ISSUE: Potassium test results on the GEM Premier 4000 are too low when compared to a reference analyzer; with biases exceeding the allowable error claim of plus or minus 0.5 mmol/L by as much as 2.0 mmol/L. Use of this product may lead to inappropriate patient treatment and may cause serious adverse health consequences, including death. These products were manufactured and distributed from May, 2006 through July 2011.

BACKGROUND: The GEM Premier 4000 PAK cartridges are used on the GEM Premier 4000 portable critical care system by health care professionals to rapidly analyze whole blood samples at the point of health care delivery in a clinical setting and in a central laboratory.

RECOMMENDATION: Customers were directed to follow the instructions to disable the potassium test to eliminate the potential of erroneous result reporting. See the Class I recall notice for more information, including affected model/part numbers.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

 

[08/01/2011 - Recall Notice - FDA]

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